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Combination attachable delivery unit (YC-1800)

FDA UDI

Class II (US FDA UDI)

by Nidek, Inc.

Identity

Trade Name
Combination attachable delivery unit (YC-1800) FDA UDI
Generic Name
General/multiple surgical frequency-doubled solid-state laser system FDA UDI
Device Name
This combination delivery unit is need to comprise the combination system which enables you to emit the green laser beam or YAG laser beam while performing the observation with the slit lamp of the YAG laser system. This delivery unit is mounted on the slit lamp of the YAG laser system and connected to the NIDEK GREEN LASER PHOTOCOAGULATOR GYC-1000 using the connecting cable and fiber optic cable. The combination system allows selection between photocoagulation with the green laser beam (wavelength: 532 nm (continuous wave)) and photodisruption with the Nd:YAG laser beam (wavelength: 1064 nm (pulse laser)). In addition, they are selected easily by changing the optical path of the laser beam with the laser select lever, and various kinds of safety devices are integrated into the system so that only the selected laser beam is emitted. The GYC2SZ-3A is the only combination delivery unit that can be connected both to the NIDEK GREEN LASER PHOTOCOAGULATOR GYC-1000 and the NIDEK OPHTHALMIC YAG LASER SYSTEM YC-1800. FDA UDI
Model / Reference
17148-0000 FDA UDI
Description
This combination delivery unit is need to comprise the combination system which enables you to emit the green laser beam or YAG laser beam while performing the observation with the slit lamp of the YAG laser system. This delivery unit is mounted on the slit lamp of the YAG laser system and connected to the NIDEK GREEN LASER PHOTOCOAGULATOR GYC-1000 using the connecting cable and fiber optic cable. The combination system allows selection between photocoagulation with the green laser beam (wavelength: 532 nm (continuous wave)) and photodisruption with the Nd:YAG laser beam (wavelength: 1064 nm (pulse laser)). In addition, they are selected easily by changing the optical path of the laser beam with the laser select lever, and various kinds of safety devices are integrated into the system so that only the selected laser beam is emitted. The GYC2SZ-3A is the only combination delivery unit that can be connected both to the NIDEK GREEN LASER PHOTOCOAGULATOR GYC-1000 and the NIDEK OPHTHALMIC YAG LASER SYSTEM YC-1800. FDA UDI

Identifiers

Primary DI / UDI-DI
04987669100318 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical frequency-doubled solid-state laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General/multiple surgical frequency-doubled solid-state laser system

Combination attachable delivery unit (YC-1800) by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General/multiple surgical frequency-doubled solid-state laser system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nidek, Inc.

Sources (1)

  • FDA UDI b558542b-43a1-4f1a-96c8-5b99fdd6230f 34 fields · synced May 29, 2026